Device for determination of an analyte in a body fluid

Abstract

A strip for testing for the presence of an analyte generally comprises a support member which contains a spreading layer and a reagent layer, and a capillary tube in communication with the support layer and spreading layer for transporting a sample of body fluid thereto. A method of testing a fluid for the presence or concentration of an analyte is also provided which generally includes providing a test strip with a support member, a spreading layer, and a reagent layer on the spreading layer. A capillary tube is provided on the support member whereby a fluid containing an analyte to be tested is introduced into the tube and flows through the tube to the spreading layer and contacts the reagent layer.

Description

The present invention relates to a test device and determination of a chemical or biochemical component (analyte) in an aqueous body fluid, such as whole blood. In particular the present invention relates to a dry reagent test strip from which an analyte presence and / or concentration is determined by use of an instrument. A common use of such test strips is for determination of glucose level in blood by diabetics.BACKGROUND OF INVENTIONNumerous devices have been developed to test for presence and quantity of analytes in aqueous samples, such as whole blood or urine. The patent and technical literature of the last thirty years is replete with inventions which utilize a reagent strip containing a dry chemistry reagent system, that is, a system in which the wet chemistries are imbibed into an absorbent or bibulous medium, dried, and later reconstituted by fluid from the test sample. The reagent strips contain an indicator which changes color, depending on the presence or concentration ...

AI Technical Summary

Problems solved by technology

The technologies embodied in the products which have been developed to date have certain limitations from the perspective of the end user and / or the manufacturer.

Colorimetric strips that dose on the meter can lead to contamination of the meter.

Further, many patients with arthritis or vision impairment have difficulty bring a drop of blood which is hanging on one of their fingers to a small application spot on the strip in the meter.

Dosing off the meter, placing the sample on the strip and then inserting it into the meter, also can still lead to contamination.

Electrochemical strips deal with the contamination issues, but the manufacturing difficulties and cost can be prohibitive.

The issue of hematocrit level affecting the accuracy of test results is a substantial one for a test device.

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